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Informal SEC investigation into Dendreon's Provenge

The Securities and Exchange Commission is informally investigating Dendreon's handling of its prostate cancer drug Provenge, which recently failed to meet FDA approval

The Securities and Exchange Commission (SEC) is informally investigating Dendreon's handling of its prostate cancer drug Provenge (sipuleucel-T), which recently failed to meet FDA approval.

In an filing made on 18 July, the Seattle-based biotechnology company revealed it had been notified earlier in the month that the SEC was investigating its clinical trials for Provenge, as well as its market application for the drug and the FDA's later review of the application.

Dendreon has stressed that the SEC's letter noted that the request should not be construed as any indication by the SEC or its staff that a violation of the federal securities laws had occurred nor should it be considered a reflection upon any person, entity or security.

The company added that it had also been accused by a shareholder of wrongful disclosure and insider trading in regards to its dealings with the FDA in early 2007 over Provenge. The shareholder in question has also requested the company's board investigate certain officers and directors. The board is presently "evaluating a response" to the letter, according to a statement.

Dendreon said it intends to fully cooperate with the SEC and will not comment further on the matter until the investigation is completed.

In March 2007, Dendreon's stock jumped nearly 150 per cent after an FDA advisory panel tentatively approved Proveng. Later in May, shares plummeted over 60 per cent when the FDA announced it would not approve the drug unless the company provided more clinical data showing efficacy in treating prostate cancer. In the same month, the company's shares rocketed up 90 per cent on news that the FDA may not need additional clinical trials.

Shares of Dendreon were down five per cent at USD 7.76 in pm trading on 17 July.

18th July 2007

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